Purpose

Revision total hip replacement using a ceramic head utilizes a titanium sleeve which introduced another articulation into the system that may lead to a local soft tissue reaction. The purpose of this study is to determine the frequency, size and types of MRI documented local tissue reactions in individuals doing well after a revision total hip replacement and ceramic bearing surface that utilizes a titanium sleeve.

Condition

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve - Patient whose age ranges from 18-99 - Patients who are not experiencing groin pain, thigh pain, or pain with ROM of the hip - Patients who are at least 2 years after a revision THA - Acetabular implant (cup) was placed in the appropriate position - Patients with a Harris Hip Score of >90

Exclusion Criteria

  • Patients who do not meet the above criteria - Patients unable to have an MRI (i.e. pacemaker, metal implants or issues with claustrophobia requiring sedation)

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Revision Total Hip Arthroplasty Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve
  • Diagnostic Test: MARS MRI
    metal artifact reduction sequence (MARS) MRI to assess for fluid collections, ATLRs or other abnormalities
  • Diagnostic Test: Titanium Labs
    Labs to look at titanium levels in blood
  • Diagnostic Test: Cobalt Labs
    Labs to look at cobalt levels in blood
  • Diagnostic Test: Chromium Labs
    Labs to look at chromium levels in blood

Recruiting Locations

Colorado Joint Replacement
Denver, Colorado 80210
Contact:
Roseann Johnson
303-260-2940

More Details

NCT ID
NCT05686915
Status
Unknown status
Sponsor
Colorado Joint Replacement

Study Contact

Roseann M Johnson, BS, CCRP
303-260-2940
roseannjohnson@centura.org

Detailed Description

Metal-on-metal total hip arthroplasty (THA) were heralded as a solution for two of the most common problems in hip arthroplasty in the last decade, instability and osteolysis. Unfortunately, their failures have led to diminished enthusiasm for this bearing surface. Adverse local tissue reactions (ATLRs) have been well documented as a means of pain and failure in this population. A recent report revealed that the most commonly used bearing surface in total hip arthroplasty, metal-on-polyethylene, may have up to a 28% incidence of MRI abnormalities in asymptomatic hips. Revision THA using a ceramic head utilizes a titanium sleeve which introduced another articulation into the system that may lead to a local soft tissue reaction. The purpose of this study is to determine the frequency, size and types of MRI documented local tissue reactions in asymptomatic individuals after a revision THA and ceramic bearing surface that utilizes a titanium sleeve. To our knowledge, this has not been studied previously and may provide important baseline features of this diagnostic tool with this particular bearing surface. We hypothesize that there will be fluid collections in a small but clinically significant portion of asymptomatic patients.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.